Zmax Compared to Augmentin in Sinusitis
Status and phase
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Details and patient eligibility
About
This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days:
- Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
- Presence of one or more of the following signs:
- Discolored (yellow-green) nasal discharge
- Discolored (yellow-green) drainage in the posterior pharynx
- Discolored (yellow-green) discharge from the maxillary sinus orifice
- Two or more of the following symptoms are present:
- Fever, as defined by:
- Oral temperature: >38C or >100.4F, or
- Tympanic temperature: >38.5C or >101.2F
- Frequent coughing
- Nasal congestion,
- Post-nasal drainage.
Exclusion criteria
- Treatment with any systemic antibiotic within 30 days prior to enrollment
- Symptoms of sinusitis lasting for longer than 30 days;
- Four or more episodes of acute sinusitis within the preceding 12 months;
Trial design
Primary purpose
Allocation
Interventional model
Masking
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Data sourced from clinicaltrials.gov
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